Nemedan

Package Leaflet: Information for the User

Nemedan, 10 mg, Coated Tablets

Memantine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Nemedan and What is it Used For
• 2. Important Information Before Taking Nemedan
• 3. How to Take Nemedan
• 4. Possible Side Effects
• 5. How to Store Nemedan
• 6. Package Contents and Other Information

1. What is Nemedan and What is it Used For

What is Nemedan

Nemedan contains the active substance memantine and belongs to a group of medications used to treat dementia.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses
that carry information in the brain. The brain has so-called N-methyl-D-aspartate (NMDA) receptors,
which are involved in transmitting nerve signals important for learning and memory processes.
Nemedan belongs to a group of medications known as NMDA receptor antagonists. By acting on NMDA receptors,
Nemedan improves the transmission of nerve impulses and memory.

What is Nemedan Used For

Nemedan is used to treat patients with moderate to severe Alzheimer's disease.

2. Important Information Before Taking Nemedan

When Not to Take Nemedan

• if the patient has been diagnosed with hypersensitivity (allergy) to memantine hydrochloride or any other component of Nemedan (see section 6).

Warnings and Precautions

When to Exercise Particular Caution When Taking Nemedan
Inform a doctor if:

• the patient has had a history of seizures;
• the patient has recently had a heart attack, has congestive heart failure, or has uncontrolled high blood pressure.

In these situations, treatment with Nemedan should be carried out under close medical supervision,
and the doctor should regularly assess the effects of therapy.
When administering memantine to patients with kidney function disorders (kidney problems),
the treating doctor should closely monitor kidney function and, if necessary, adjust the medication dosage.
Concomitant use of medications such as amantadine (for Parkinson's disease), ketamine (usually used as an anesthetic),
dextromethorphan (usually used to treat cough), and other NMDA receptor antagonist medications should be avoided.

Children and Adolescents

Nemedan is not recommended for children and adolescents under 18 years of age.

Nemedan and Other Medications

Inform the treating doctor or pharmacist about all medications currently being taken or recently taken,
even those available without a prescription.
In particular, taking Nemedan may cause changes in the effect and require dosage modification by the treating doctor of the following medications:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination medications containing hydrochlorothiazide);
• anticholinergic medications (usually used to treat movement disorders or intestinal cramps);
• antiepileptic medications (used to prevent and interrupt seizures);
• barbiturates (mainly used as sleep aids);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (used to treat mental disorders);
• oral anticoagulants.

In case of hospitalization, inform the doctor that you are taking Nemedan.

Nemedan with Food and Drink

Inform the treating doctor if the patient has recently made or plans to make significant changes to their diet (e.g., switching from a normal diet to a strict vegetarian diet) or has been diagnosed with renal tubular acidosis (RTA, excessive blood acidity due to kidney dysfunction) or severe urinary tract infections.
In these cases, the treating doctor may need to adjust the medication dosage.

Pregnancy, Breastfeeding, and Fertility

Women who are pregnant, breastfeeding, or planning to become pregnant should inform their doctor before starting treatment.
Pregnancy
Memantine is not recommended for pregnant women.
Breastfeeding
Women taking Nemedan should not breastfeed.

Driving and Operating Machinery

The treating doctor should inform the patient whether their condition allows them to safely drive and operate machinery.
Nemedan may also affect reaction speed, making driving or operating machinery inadvisable.

Nemedan Contains Lactose

The medication contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medication.

3. How to Take Nemedan

Nemedan should always be taken as directed by the treating doctor. In case of doubts, consult a doctor or pharmacist.

Dosage

The recommended dose of Nemedan for adults and the elderly is 20 mg once daily.
To minimize the risk of side effects, the dose should be increased gradually, according to the following schedule:
Usually, the initial dose is half a tablet once daily (1 x 5 mg) for the first week.
The dose is increased to one tablet once daily (1 x 10 mg) in the second week and to one and a half tablets once daily in the third week.
From the fourth week onwards, the dose usually is 2 tablets once daily (1 x 20 mg).

Dosage in Patients with Kidney Function Disorders

In patients with impaired kidney function, the treating doctor will determine the appropriate dosage.
In such patients, regular monitoring of kidney function is necessary, at intervals specified by the treating doctor.

Method of Administration

Nemedan should be taken orally, once daily. To ensure effective treatment, the medication should be taken regularly at the same time every day.
Tablets should be swallowed with water. The medication can be taken with or without food.

Duration of Treatment

Treatment should be continued as long as it is beneficial. The treating doctor should regularly assess the course of treatment.

Overdose of Nemedan

• Generally, taking too much Nemedan does not pose a risk to health. In such cases, enhanced side effects described in section 4 "Possible Side Effects" may occur.
• In case of significant overdose of Nemedan, consult a doctor, as there may be a need for appropriate action.

Missing a Dose of Nemedan

• If a patient forgets to take a dose, they should take the next dose at the usual time.
• A double dose should not be taken to make up for a missed dose.

In case of doubts about taking this medication, consult a doctor or pharmacist.

pharmacist.

4. Possible Side Effects

Like all medications, Nemedan can cause side effects, although not everybody gets them.
Generally, observed side effects are mild to moderate.
Common(may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver enzyme levels, dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medication.

Uncommon(may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous thromboembolism (thrombosis/embolism).

Rare(may affect up to 1 in 1,000 people):

• Seizures.

Unknown(frequency cannot be estimated from the available data):

• Pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with Nemedan.

Reporting Side Effects

If side effects occur, including those not listed in this package leaflet, inform a doctor or pharmacist.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Nemedan

Store the medication out of sight and reach of children.
Do not use Nemedan after the expiration date stated on the package and blister after the words "Expiration Date".
The expiration date refers to the last day of the given month.
No special precautions are required for storing the medicinal product.
Divided or whole tablets, once removed from the blister, can be stored for up to 7 days (e.g., in a pillbox).
Medications should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medications.
This will help protect the environment.

6. Package Contents and Other Information

What Nemedan Contains

The active substance of Nemedan is memantine hydrochloride. Each coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
Other ingredients are:
Tablet core: microcrystalline cellulose, lactose DC (consisting of lactose monohydrate, Povidone K 30), colloidal silicon dioxide, talc, magnesium stearate; and
Tablet coating Opadry White Y-1-7000: hypromellose 5 cp, titanium dioxide (E 171), macrogol

• 400.

What Nemedan Looks Like and Package Contents

Nemedan coated tablets are white or almost white, elongated, biconvex, coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Nemedan coated tablets are available in blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer/Importer

G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
To obtain more detailed information and information on the names of the medicinal product in other EEA member states, contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of Last Revision of the Package Leaflet: